FDA.reportPublic FDA data

INTENSA

Primary DI
M368650T2RGH1
Brand
INTENSA
Company
GF HEALTH PRODUCTS, INC.
Model
650-T2-RGH
Device description
BLOOD DONOR CHR, RGH ADJ ARMS
Published
2025-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMLChair, Blood Donor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMLChair, Blood DonorGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368650T2RGH1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor chair/couchA mains electricity (AC-powered) device used to position the patient in such a manner that a technician/nurse has easy access to the patient's arm for drawing blood. The armboard, that is attached to the chair, typically has lateral and height adjustments so that the patient's arm can be positioned in a location that is easily accessible to whoever is drawing the blood sample. This chair is electrically motorized and can be adjusted so that the donor can lie in a reclining position.

Contacts#

Phone, Email table
PhoneEmail
770-368-4700CS@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M368650T2LFT1INTENSAGF HEALTH PRODUCTS, INC.FML2025-10-31
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00817517027945Marketlab-ClintonMARKETLAB INC.FML2024-02-02
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00817517028164Marketlab-ClintonMARKETLAB INC.FML2024-02-02
00817517028171Marketlab-ClintonMARKETLAB INC.FML2024-02-02
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00817517028195Marketlab-ClintonMARKETLAB INC.FML2024-02-02
00817517028201Marketlab-ClintonMARKETLAB INC.FML2024-02-02
00817517028218Marketlab-ClintonMARKETLAB INC.FML2024-02-02
00817517028225Marketlab-ClintonMARKETLAB INC.FML2024-02-02
00817517028232Marketlab-ClintonMARKETLAB INC.FML2024-02-02
00817517028249Marketlab-ClintonMARKETLAB INC.FML2024-02-02
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00817517028270Marketlab-ClintonMARKETLAB INC.FML2024-02-02